This phase II study will evaluate the efficacy of the combination of two monoclonal antibodies (Avastin + Erbitux) with irinotecan, in patients with colorectal cancer progressed after 1st line treatment with FOLFIRI Avastin or XELIRI Avastin.
Treating patients with primary resistance to the most active multi-agent combination remains a challenging clinical problem. The reported data demonstrated that addition of ERBITUX may reverse IRINOTECAN resistance. Further data support the feasibility of the combination of two monoclonal antibodies (AVASTIN+ERBITUX) with IRINOTECAN with better responses compared to historical controls (ERBITUX±IRINOTECAN). As such, a phase II study was designed to evaluate the efficacy of the combination of AVASTIN plus ERBITUX plus IRINOTECAN as second line treatment in patients progressing while on treatment with FOLFIRI AVASTIN or XELIRI AVASTIN
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression
Avastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression
Erbitux (IV)500 mg/m2 on day 1 every two weeks until progression
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
401 Military Hospital of Athens
Athens, Greece
: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
Air Forces Military Hospital of Athens
Time To Progression
Time frame: 1 year
Objective Response Rate
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Toxicity profile
Time frame: Toxicity assessment on each chemotherapy cycle
Quality of life, Symptoms improvement
Time frame: Assessment every two cycles
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Athens, Greece
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
State General Hospital of Larissa
Larissa, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece